Institutional Review Board, Hospital for Special Surgery
July 23, 2015
The safety of study participants is our top priority. The trial is approved and periodically reviewed by an Institutional Review Board (IRB), which includes doctors, administrators, ethicists, and members of the general public. The safety of clinical trials is reviewed by the U.S. Food and Drug Administration.
Before enrolling in a clinical trial, the investigator will explain the purpose of the trial, its expected benefits, any possible risks or side effects, and what your role will be. This is the time to ask questions! If you want to join the trial, you must sign the informed consent documents. You can leave a clinical trial at any time without penalty.
For further information, see Understanding Clinical Trials.
• Patients over 18 years of age
• Patients with single- or multi-level spinal stenosis undergoing open lumbar laminectomy or Patients with single-level herniated nucleus pulposus undergoing single-level lumbar microdiscectomy
• Ability to provide full written consent
• Patients under the age 18 years of age
• Non-English speaking patients
• Non-surgical candidate defined as any patient deemed by the surgeon not to be a surgical candidate cannot participate for the following reasons: that patient does not meet indications for lumbar laminectomy or microdiscectomy surgery, patient has a contraindication to surgery such as medical comorbidities, pregnancy, etc.
• Patient allergic to aminoglycosides • Is a prisoner • Is involved in worker’s compensation or other litigation relative to the spine injury
• Has a history of drug or alcohol abuse within the last 12 months
• Is currently participating in another drug or device clinical trial
• Previous spinal surgery
• Patients with history of deformity, mechanical instability, or spinal fusion requirement
• History of hard- or soft-tissue spinal infection
• Has signs or symptoms of any disease, such as autoimmune disease, which could result in allograft failure, or has experienced allograft failure in the past
• Patients unable to undergo a MRI
• Patients unwilling or unable to return for routine follow-up or complete outcome instruments at the specified timepoints pre-and post-operatively
Mohamed Moawad, BA